Issued to Immunomedics, Inc. Application reviewed but not approved; deficiencies must be corrected.
Issued
January 17, 2019Application
BLA • 761115
Product
TRODELVY
Company
Immunomedics, Inc
Review center
Other
Stage
Final Decision
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events, Chemistry, manufacturing, and controls, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
Review the exact redacted FDA letter and address each stated deficiency before resubmission.
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Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Immunomedics, Inc on January 17, 2019.
BLA 761115 is the application under which FDA issued this complete response letter for TRODELVY to Immunomedics, Inc. It was reviewed by FDA Other. The letter is dated January 17, 2019.
FDA will not approve the application in its present form. The sponsor can resubmit after addressing every deficiency listed in the letter — which starts a Class 1 (two-month) or Class 2 (six-month) resubmission review clock — withdraw the application, or request an opportunity for a hearing.